PIONEER SPINOUS PROCESS FUSION PLATE

{0}------------------------------------------------ K101525 ## 510(k) SUMMARY OCT 2 2 2010 ## Pioneer Spinous Process Fusion Plate | Sponsor: | Manufacturer | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855 | |-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | | Official Contact<br>Phone:<br>Fax: | Emily M. Downs<br>(906) 225-5602<br>(906) 226-4459 | | | Representative/<br>Consultant:<br>Phone:<br>Fax: | Barry E. Sands<br>978-363-5277<br>978-477-0206 | | | Date prepared: | October 21, 2010 | | Device Name: | Pioneer Spinous Process Fusion Plate | | | Classification<br>Name: | Spinal Interlaminal Fixation Orthosis | | | Classification<br>Number: | Product Code/Classification Number:<br>KWP/ 888.3050 – Spinal Interlaminal Fixation Orthosis<br>Class II | | | Description: | The Pioneer Spinous Process Fusion Plate is a plate with spacer system<br>designed to provide posterior fixation by physically linking adjacent spinous<br>processes. | | | | All components of the Pioneer Spinous Process Fusion Plate are comprised of<br>Titanium Alloy Ti6Al4V per ASTM F136. | | | | The system also contains Class 1 manual surgical instruments and cases that<br>are considered exempt from premarket notification. | | | Intended Use: | The Pioneer Spinous Process Fusion Plate is a posterior, non-pedicle<br>supplemental fixation device intended for use at a single level in the non-<br>cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous<br>processes for the purpose of achieving supplemental fusion in the following<br>conditions: degenerative disc disease (defined as discogenic back pain with<br>degeneration of the disc confirmed by history and radiographic studies);<br>spondylolisthesis, trauma and/or tumor. The Pioneer Spinous Process Fusion<br>System is intended for use with bone graft material (i.e. allograph or<br>autograph), not intended for stand-alone use. | | | Material: | The Pioneer Spinous Process Fusion Plate is composed of Ti Alloy per ASTM<br>F136. The predicate device is composed of the same material. | | | Comparison to<br>Predicate<br>Devices | The indication for use of the Pioneer Spinous Process Fusion Plate is the<br>same as the predicate device. Implant material, mechanism of action, and<br>available sizes for the Pioneer Spinous Process Fusion plate are identical to<br>that of predicate systems.. | | | Performance<br>Data: | A dimensional comparison between the subject and predicate Spinous<br>Process Fusion Plate devices demonstrated that no significant differences<br>exist that would impact strength or function. This analysis concluded that<br>the two devices were equivalent in terms of safety and effectiveness.<br><br>In addition, static and fatigue disassociation testing at the locking interface<br>between the screw and barrel was conducted on the Pioneer Spinous<br>Process Fusion Plate and found to be equivalent to the predicate device. | | | Performance<br>and SE<br>Determination: | Equivalence for Pioneer Spinous Process Fusion System is based on<br>similarities of intended use, design, and physical characteristics when<br>compared to predicate devices. Therefore, Pioneer Surgical Technology<br>believes that there is sufficient evidence to conclude that the Pioneer<br>Spinous Process Fusion Plate System is substantially equivalent to existing<br>legally marketed devices. | | 1 of 2 {1}------------------------------------------------ '4 . 2 of 2 . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the seal is an abstract image of an eagle or bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 Pioneer Surgical Technology, Inc. % Ms. Emily M. Downs Manager, Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855 OCT 2 2 2010 Re: K101525 Trade/Device Name: Pioneer Spinous Process Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: October 11, 2010 Received: October 12, 2010 Dear Ms. Downs: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 {3}------------------------------------------------ Page 2 - Ms. Emily M. Downs CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set . forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.hym for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Sincerely yours, Mark A. Milliken Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## K101525 ## Indications for Use Statement 510(k) Number (if known): K101525 Device Name: Pioneer Spinous Process Fusion Plate Indications: 0CT 2 2 2010 The Pioneer Spinous Process Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis, trauma (i.e., fracture or dislocation); and/or tumor. The Pioneer SPFP is intended for use with bone graft material (i.e. allograph or autograph), not intended for stand-alone use. > Prescription Use __ V (Per 21 CFR 801.109) Over-the-Counter Use (Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) OR Concurrence of CDRH, Office of Device Evaluation (ODE) Page _1_ of _1_ Mark A. Miller (Division of Surgical, Orthopedic, and Restorative Devices K101525 510(k) Number lof